| Device |
chest x-ray computer aided detection |
| Regulation Description |
Picture archiving and communications system. |
| Definition |
To assist radiologists in the review of chest radiographic images and highlight potential nodules that the radiologist should review. |
| Physical State |
Software device. |
| Technical Method |
Detection algorithm searches for and identifies potential nodules on images of the chest acquired using x-ray. |
| Target Area |
Chest |
| Regulation Medical Specialty |
Radiology |
| Review Panel |
Radiology |
|---|
| Product Code | OMJ |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
892.2050
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Guidance Document
- Guidance for Industry and Food and Drug Administration Staff - Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions
![[http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm187249.htm]](../images/linker1.gif)
|
|
| Third Party Review |
Not Third Party Eligible |
